Senior Quality Engineer NPD

Imagine how your ideas and expertise can change a patients life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. Youll bring your passion for problem solving and partner with various teams to influence decision-making for a products entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.

Aortic stenosis impacts millions of people globally yet it often remains under-diagnosed and under-treated. Edwards groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. Its our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. You will apply your knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards systems/procedures to optimize product development internal and external device manufacturing and device distribution.

How you will make an impact:
Owns design assurance and development activities (i.e. requirement development risk assessment engineering study feasibility testing drawing review etc.) for New Product Development program

Participates in test method development/validation activities for New Product Development programs.

Collaborate with the R&D and Sustaining organizations to help facilitate the successful execution of the NPD process and launching of robust products

Develop experiments and tests (including writing and executing protocols) to create validate and improve products (including evaluation of source materials and suppliers) and manufacturing processes/methods based on engineering principles; analyze results make recommendations and develop reports.

Implement and monitor Critical Control Points.
Develop update and maintain technical content of risk management files (e.g. FMEAs Quality Control Plans).
Develop training and documentation materials for production and Receiving Inspection (e.g. work instructions) to enable the seamless knowledge transfer of project and manufacturing processes.

Implement and approve compliant change control.
Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
Train coach and guide lower level employees on routine procedures
Other incidental duties assigned by Leadership

What youll need (Required):
Bachelors Degree in in Engineering or related field 4 years related industry experience or
Masters Degree or equivalent in in Engineering or related field 3 years experience related industry or industry/education experience or
Ph.D. or equivalent in in Engineering or related field 0 years experience

What else we look for (Preferred):
Proven expertise in usage of MS Office Suite
Strong documentation communication and interpersonal relationship skills including negotiating and relationship management skills
Working knowledge and understanding of statistical techniques
Previous experience working with lab/industrial equipment required
Substantial understanding and knowledge of principles theories and concepts relevant to Engineering
Strong problem-solving organizational analytical and critical thinking skills
Substantial understanding of processes and equipment used in assigned work
Good leadership skills and ability to influence change
Knowledge of and adherence to Quality systems
Strict attention to detail
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast paced environment
Must be able to work in a team environment including inter-departmental teams and key contact representing the organization on contracts or projects
Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
Adhere to all company rules and requirements (e.g. pandemic protocols Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

Aligning our overall business objectives with performance we offer competitive salaries performance-based incentives and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
For California (CA) the base pay range for this position is $108000 to $153000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g. qualifications education prior experience). Applications will be accepted while this position is posted on our Careers website.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role as a condition of employment you will be required to submit proof that you have been vaccinated for COVID-19 unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.